Recall Z-0067-2017 ยท BSR Stylet, Tracheal Tube
Brathwaites Oliver Medical
The Introes Pocket Bougie is an endotracheal tube introducer. The device is an endotracheal tube introducer and it is used as a guide during intubation. Anesthesiology.
| Date | Oct 11, 2016 (initiated Aug 19, 2016) |
| Status | Terminated |
| Reason | The Introes Pocket Bougie an endotracheal tube introducer size 14 Fr (4.7mm) x 60 cm may break during intubation. |
| Root cause | Nonconforming Material/Component |
| Action | On August 19, 2016 the firm sent a MEDICAL DEVICE RECALL NOTICE & CORRECTIVE ACTION letter to affected customers. The letter described the reason for the recall and necessary actions to be taken by the consignees. These included: BOMImed is requesting bougies with lot# 101615 to be returned for evaluation due a potential manufacturing concern. Complete the included Medical Device Recall Customer Letter and follow the instructions to obtain a Return Material Authorization number and applicable shipping instructions to return the affected products. BOMImed Regulatory department also requires |
| Quantity | 760 units |
| Distribution | U.S. Consignee located in the following states: IL, WI, WE, OR, NY, UT, IN, NE, PA, MO, OH, AZ, MA, CT and NC.*** Foreign Consignee: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.